Back to resultsA Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002
Primary Purpose
Pancreatic Cancer, Carcinoma, Pancreatic Ductal, Pancreatic Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AGS-1C4D4
gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Gemcitabine, ASP6182, AGS-1C4D4, Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Subject has stable disease or better per Response Evaluation Criteria in Solid Tumors (RECIST) criteria v.1.1. in Protocol 2008002
Exclusion Criteria:
- More than 6 weeks (2 doses) has lapsed from the time of the last infusion in AGS-1C4D4 Protocol 2008002
Use of the following prohibited medications / therapies:
- Monoclonal antibody therapy, other than AGS-1C4D4
- Chemotherapy, other than gemcitabine
- Investigational therapy other than AGS-1C4D4
- Erlotinib (Tarceva)
- Any clinical condition which would not allow safe conduct of this study
Sites / Locations
- Site US116
- Site CA00203
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AGS-1C4D4 plus gemcitabine
Arm Description
Subjects will receive a maintenance dose of AGS-1C4D4 every 3 weeks (Q3W) in addition to the gemcitabine administration.
Outcomes
Primary Outcome Measures
Incidence of adverse events
Grade 3 and 4 adverse events, treatment-related adverse events, serious adverse events and adverse events requiring discontinuation of AGS-1C4D4
Incidence of anti-AGS-1C4D4 antibody formation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01608711
Brief Title
A Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002
Official Title
An Open-Label Phase 2 Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 7, 2012 (Actual)
Primary Completion Date
November 16, 2015 (Actual)
Study Completion Date
November 16, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Agensys, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to continue the safety and immunogenicity of AGS-1C4D4 administered in combination with gemcitabine in subjects previously treated in protocol 2008002.
Detailed Description
Subjects will receive a maintenance dose of AGS-1C4D4 every 3 weeks (Q3W) in addition to the gemcitabine administration. If subjects have grade 4 adverse events considered to be related to AGS-1C4D4 at anytime during the study, AGS-1C4D4 treatment will be discontinued for that subject.
Subjects will continue to have their tumor status assessed by computerized tomography (CT) and magnetic resonance (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) guidelines every eight weeks (Q8W). Subjects without evidence of disease progression will continue to receive AGS-1C4D4 and gemcitabine until intolerability, disease progression or consent withdrawal.
Subjects who discontinue AGS-1C4D4 for any reason will undergo an end of study visit 4 weeks after their last AGS-1C4D4 infusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Carcinoma, Pancreatic Ductal, Pancreatic Disease
Keywords
Gemcitabine, ASP6182, AGS-1C4D4, Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AGS-1C4D4 plus gemcitabine
Arm Type
Experimental
Arm Description
Subjects will receive a maintenance dose of AGS-1C4D4 every 3 weeks (Q3W) in addition to the gemcitabine administration.
Intervention Type
Biological
Intervention Name(s)
AGS-1C4D4
Other Intervention Name(s)
ASP6182
Intervention Description
Intravenous Infusion
Intervention Type
Biological
Intervention Name(s)
gemcitabine
Intervention Description
Intravenous Infusion
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Grade 3 and 4 adverse events, treatment-related adverse events, serious adverse events and adverse events requiring discontinuation of AGS-1C4D4
Time Frame
31 months
Title
Incidence of anti-AGS-1C4D4 antibody formation
Time Frame
Every 8 weeks (up to 31 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has stable disease or better per Response Evaluation Criteria in Solid Tumors (RECIST) criteria v.1.1. in Protocol 2008002
Exclusion Criteria:
More than 6 weeks (2 doses) has lapsed from the time of the last infusion in AGS-1C4D4 Protocol 2008002
Use of the following prohibited medications / therapies:
Monoclonal antibody therapy, other than AGS-1C4D4
Chemotherapy, other than gemcitabine
Investigational therapy other than AGS-1C4D4
Erlotinib (Tarceva)
Any clinical condition which would not allow safe conduct of this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Agensys, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Site US116
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Site CA00203
City
Toronto
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002
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